If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.
The Director of PV Operations plays a crucial and impactful role in the Zanidatamab asset and future asset acquisitions. Focused on global expansion and clinical development asset acquisition in the US and emerging markets such as Japan, the Director will bring creative and strategic thinking to PV Operations, serving as the SME on cross-functional teams.
The Director will be deeply involved in developing, coordinating, and executing asset integration plans, collaborating closely with stakeholders to transition the safety database, associated processes, and relevant SOPs into Jazz's established safety system.
This essential role supports Jazz’s commitment to delivering quality medications to patients and propelling the company towards the mission of prioritizing patient care. The Director will also advance Pharmacovigilance science and practice by mentoring team members, identifying business development opportunities, establishing service lines, participating in talent acquisition, and engaging with GRADS leadership on PV Operations advancement and growth.
Essential Functions/Responsibilities
The GRADS Director of PV Operations responsibilities may include activities such as, but not limited to:
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Providing expert safety input and review of study specific documents (e.g. protocols, IBs, IMPDs, clinical study reports, INDs, CTAs)
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Provide expert knowledge on PV global regulations, guidelines and industry best practices
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Collaborate with key internal and external stakeholders, as well as business partners, to identify integration needs related to safety systems and PV operations.
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Collaborate with Safety Systems team, to support validation , data migration and associated change management actions.
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Proactively identify process gaps and implement mitigations to ensure smooth migration and integration of safety data.
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Oversee case processing activities for Jazz’s clinical development program, serving as the subject matter expert on regulations and best practices for handling safety data in Jazz’s global safety database.
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Developing Clinical Trial PV training materials to support new and existing projects
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Monitor compliance and compliance metrics and KPIs.
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Departmental Strategic planning, budgeting, and training.
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Provide direction and leadership on safety vendor management, including the oversight of all operational aspects of outsourced drug safety and pharmacovigilance.
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Manage contracted PV service providers, ensuring resources are available to quickly pivot and prioritize new activities related to Zanidatamab and other newly acquired assets.
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Develop best practices and processes, providing leadership and direction in these areas.
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Manage, mentor, and develop direct reports in the Global Case Processing, Intake, and Submissions teams, including succession planning for key functions.
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Provide expertise, leadership, and guidance to the Global Case Management team on day-to-day activities and prioritized tasks such as storyboard development and inspection readiness preparation.
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Facilitate cross-functional safety reviews with study physician team members.
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Offer subject matter expertise for regulatory submissions and collaborate with cross-functional areas as needed.
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Collaborate with the Jazz SSM team to ensure updated regulatory reporting rules and intelligence are in place for timely submission of expedited safety reports, tracking submission information in the safety database.
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Develop and refine SOPs, providing operational input to execute best pharmacovigilance practices and maintain regulatory compliance.
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Maintain SOPs, WIs and controlled procedural documents and tools in collaboration with cross functional teams, business partners, CROs and vendors.
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Provide operational leadership for case management workflow, overseeing case processing activities, and ensuring critical timelines, budget, and compliance metrics are met.
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Work closely with the Jazz IS team to develop processes and oversee data security, data protection, disaster recovery, and business continuity for the safety database.
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Lead the preparation, authoring, and review of responses to health authority queries and CAPAs.
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Drive the completion of audit CAPAs and other compliance documentation.
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Collaborate with clinical teams, data management, and other stakeholders to develop data quality standards for clinical studies, organized data collection programs, literature, and spontaneous sources.
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Prioritize activities delegated by the QPPV as detailed in the PV System Master File, maintaining a state of inspection readiness.
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Develop, model, and foster a culture of quality, compliance, diversity, inclusion, and learning within the GCM team and GRADS.
Required Knowledge, Skills, and Abilities
- Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS
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Knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area
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Experience managing relationships with service providers or external business partners
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Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships
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Excellent oral and written communication skills, demonstrating professional maturity(high emotional IQ), confidence and competence
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Ability to work effectively within a matrix organization to achieve desired outcomes
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Track record of effective decision-making
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Excellent conflict management/resolution skills
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Proven ability to demonstrate Jazz values and leadership competencies
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Ability to work across cultures, including in a virtual environment
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Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
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Team Building, Motivating and Influencing Others without authority
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Promoting Innovation and Process Improvement Maintaining activities
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Negotiation skills, strong analytical skills. Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills
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Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
Required/Preferred Education and Licenses
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Bachelor’s degree in life sciences or a related field. Nursing RN/BSNMSN , or PharmD strongly preferred.
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Minimum of 8 years of experience with a demonstrated focus on PV operations and compliance, including at least 2 years of direct supervisory experience.
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Hands-on experience with validated safety databases, such as Argus.
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In-depth knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP).
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Comprehensive understanding of pharmacovigilance regulations in the US (CFR) and Europe (GVP).
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Thorough knowledge of Individual Case Safety Reports (ICSR) processing operations, including collaboration with outsourced vendors and Contract Research Organizations, covering all steps from case receipt to processing, medical review, regulatory submission, and issuing follow-up queries.
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Excellent written and verbal communication skills, with the ability to convey complex information and concepts clearly.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $196,000.00 - $294,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.